For Immediate Release
THOUSAND OAKS, Calif. -- January 23, 2003 ??? Amgen (Nasdaq: AMGN),
announced today that rHu-KGF decreased the duration and incidence of severe
oral mucositis in a phase 3 study of patients undergoing bone marrow
transplantation treatment for hematologic malignancies such as lymphoma,
multiple myeloma, and leukemia.
Natural keratinocyte growth factor stimulates the growth and development of
epithelial cells, including the cells that line the gastrointestinal tract. Amgen is
studying a recombinant human keratinocyte growth factor (rHu-KGF) to protect
epithelial cells from injury caused by anti-tumor treatments such as radiation and
chemotherapy. Mucositis is a painful and debilitating condition in which patients
experience severe mouth ulcerations that can make swallowing difficult or
Preliminary results from the Phase 3 randomized, double blind trial were positive
on all end-points showing highly significant decrease in both the duration and
incidence of severe mucositis. The trial also showed that KGF was well
Roger Perlmutter, Amgen´s executive vice president of research and
development, said: ???There is no currently approved therapy to treat oral
mucositis, a sometimes devastating complication of cancer chemotherapy. We
are looking forward to discussing our phase 3 results that address this critical
unmet medical need with regulatory agencies in the near future.???
Amgen will now investigate the efficacy and safety of KGF in other patient
populations who suffer from high rates of mucositis associated with their antitumor
This news release contains forward-looking statements that involve significant
risks and uncertainties, including those discussed below and more fully described
in the Securities and Exchange Commission reports filed by Amgen, including
our most recent Form 10-Q. Amgen conducts research in the
biotechnology/pharmaceutical field where movement from concept to product is
uncertain; consequently, there can be no guarantee that any particular product
candidate will be successful and become a commercial product.
Furthermore, our research, testing, pricing, marketing and other operations are
subject to extensive regulation by domestic and foreign government regulatory
authorities. In addition, sales of our products are affected by reimbursement
policies imposed by third party payors, including governments, private insurance
plans and managed care providers. These government regulations and
reimbursement policies may affect the development, usage and pricing of our
In addition, while we routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be challenged,
invalidated or circumvented by our competitors.
Because forward-looking statements involve risks and uncertainties, actual
results may differ materially from current results expected by Amgen. Amgen is
providing this information as of January 23, 2003 and expressly disclaims any
duty to update information contained in this press release.
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on advances in
cellular and molecular biology.
CONTACT: Amgen, Thousand Oaks
Jeff Richardson, 805/447-3227 (media)
Cary Rosansky, 805/447-4634 (investors)